Pharm Exec's 2013 Pipeline Report - Pharmaceutical Executive

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Pharm Exec's 2013 Pipeline Report


Pharmaceutical Executive


Diabetes: Incremental Improvement




Unfortunately for type 1 diabetes patients, there isn't much to get excited about in terms of new pharmaceutical products, at least in the short term. New longer-acting insulin replacement therapies are coming from Novo Nordisk, namely Tresiba (degludec) and Ryzodeg (degludecplus), but they aren't much different from what's already available. Tresiba, an "ultra" long-acting insulin therapy with a duration of action that exceeds 24 hours, would compete directly against Sanofi's long-acting insulin Lantus, which only works for 24 hours. Ryzodeg, another "ultra" long-acting insulin, in Novo Nordisk's parlance, has a similar duration of action, but adds insulin aspart, a rapid-acting insulin used at mealtime. Ryzogdeg would likely be administered once a day before a meal, but would still require additional rapid-acting insulin injections prior to successive meals throughout the day.

Novo Nordisk has suggested that their degludec products show an added benefit over Lantus in the form of fewer instances of hypoglycemia, or dangerously low blood sugar levels. Sanofi has rebuffed that suggestion, claiming that Novo "unfairly stacked the deck against [Sanofi] in the design of their clinical trials," wrote Tim Anderson of Bernstein Research in a note to investors. FDA announced that it would convene a committee meeting to discuss cardiovascular risks associated with Novo's two degludec products, and also to discuss the merits and potential benefits surrounding the hypoglycemia-related benefit claims. "As only a few of the degludec clinical trials have been published in full, it is difficult to determine how strong the cardiovascular 'signal' with degludec is," wrote Anderson. Lantus is expected to earn over $6 billion in global sales this year—11 percent of Sanofi's total companywide sales—so what Novo can and can't claim if Tresiba and Ryzodeg receive approval will matter a lot to Sanofi. There isn't much of a distinction between these new products and Lantus, in terms of meaningful efficacy or product attributes, so marketing prowess around the world is an outsized factor in gaining or losing market share in the straight insulin game. "In emerging markets, Novo Nordisk has an indisputable edge," notes Selvaraju. "Particularly in China, no one can challenge Novo Nordisk in the diabetes space."

Lilly and Boehringer Ingelheim hope to pitch their own jointly-developed versions of long-acting insulin—LY2605541 and LY2963016—into the mix. Phase III trials taking on Lantus head-to-head are currently underway in both type 1 and type 2 patients. Reports from one such study suggested comparable efficacy, but indicated a weight loss benefit with Lilly/Boehringer's LY2605541. If that benefit holds through additional trials, it could provide a significant advantage over competing therapies.

Beyond pure insulin therapies, J&J's SGLT2 canagliflozin continues to amass mostly positive data, including a Phase III trial that showed the compound outperforming Merck's type 2 blockbuster drug Januvia. Studies also indicate a slight weight loss benefit with canagliflozin, but if history is any guide, FDA will be meticulous—to put it mildly—in scrutinizing the drug's safety profile before making a decision. If approved, Canagliflozin would be first SGLT2 to market; BMS/AstraZeneca's SGLT2, dapagliflozin, had been leading the way, but got pulled out of line after FDA issued a complete response letter requiring more safety data. European regulators haven't shown as much concern over dapagliflozin; the EMA recommended approval last April. Sales of canagliflozin, if approved, will hit $1.2 billion by 2015, according to Adis Insight.

Despite a crowded landscape—if an SGLT2 is approved, it will face off against GLP-1s like Novo's Victoza and Amylin/Alkermes Bydureon, and DPP4s like Merck's Januvia, BMS/AZ's Onglyza and Lilly/Boehringer Ingelheim's Tradjenta—there's room to grow, with the market for type 2 diabetes drugs nearly doubling, from $26 billion in 2011 to $50 billion in 2022, according to Decision Resources.


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